Team Approach to Polypharmacy Evaluation and Reduction (TAPER-RCT)

Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial

In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.

This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.

Patients, aged 70 years of age or older and are taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow up systems.

This study will examine effects on patient and health relevant outcome measures as well as qualitative research exploring patients' and clinicians' experiences of reducing medication burden. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.

Study Overview

• Status: Completed
• Conditions: Polypharmacy; Multi-morbidity; Medication Therapy Management
• Intervention / Treatment: Other: Medication reduction

Detailed Description

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. Initial baseline data collection from the patient include data on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Dr. Dee Mangin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 70 years of age or older
• Patient must have a family doctor
• Participating family doctor as most responsible provider
• Currently taking more 5 or more long-term medications
• Have not had a recent (past 12 months) comprehensive medication review
• Patient willing to try discontinuation

Exclusion Criteria:

• English language or cognitive skills inadequate to understand and respond to rating scales
• Terminal illness or other circumstance precluding 6 month study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAPER; The intervention is medication reduction. This arm is comprised of: Medication reconciliation; Identification of patient priorities for care; Identification of medications that are potentially appropriate for discontinuation/dose reduction; Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce; Identification of medications for trial of discontinuation/dose reduction (shared decision making); Pause of medication and clinical monitoring	Other: Medication reduction; Systematic approach to reduction in polypharmacy.; Other Names: Medication discontinuation/dose reduction
No Intervention: Control; Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful discontinuation (mean difference in number of medications)	Difference in mean number of medications	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (EQ5D-5L)	EuroQol five dimensions questionnaire (EQ5D-5L)	Baseline, 6 months
Quality of life (SF36v2)	The Short Form (36) Health Survey (SF-36-V2)	Baseline, 6 months
Cognition	The Mini Mental Status Examination (MMSE)	Baseline, 6 months
Fatigue	Avlund Mob-T Scale	Baseline, 6 months
Patient enablement	The Patient Enablement Index (PEI)	Baseline, 6 months
Sleep	15-D Scale (Sleep Question)	Baseline, 6 months
Disease burden	Disease Burden Survey (Bayliss et al., 2009)	Baseline, 6 months
Nutritional status	Mini Nutritional Assessment Short-Form (MNA-SF)	Baseline, 6 months
Treatment burden	Brief Treatment Burden Scale	Baseline, 6 months
Falls	Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient	Baseline, 6 months
Physical functional capacity and ability	Manty structured validated interview	Baseline, 6 months
Physical function capacity and ability (timed-up-and-go)	Timed up and go test (TUG)	Baseline, 6 months
Physical function capacity and ability (strength)	Grip strength	Baseline, 6 month
Physical function capacity and ability (balance)	Global Rating of Change (Balance)	Baseline, 6 months
Healthcare resource utilization (hospital admissions)	Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization	Baseline, 6 months
Healthcare resource utilization (ED/urgent care visits)	Number of emergency department and urgent care visits from administrative data and self-report	Baseline, 6 months
Healthcare resource utilization (primary care visits)	Number of primary care visits from administrative data	baseline, 6 months
Successful discontinuation or dose reduction	Composite variable calculate to represent mean number of medications stopped or dose reductions	6 months
Successful discontinuation or dose reduction (proportion)	Proportion of patients with successful discontinuations or dose reductions	6 months
Changes in medication side effects and symptoms (adverse)	Patient self-report of appearance (new or worsening) of side effects associated with medications	1 week, 3 month, 6 month
Changes in medication side effects and symptoms (positive)	Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications	1 week, 3 month, 6 month
Serious adverse events	Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products)	3 months, 6 months
Medication self-efficacy	Self-efficacy for appropriate mediation use scale	Baseline, 6 months
Patient experience of pain	Brief Pain Inventory (Pain interference and Pain severity sub-scales)	Baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation processes	NoMAD survey	baseline, 3 months, 6 months
Pharmacists/family physician 5 best/worst aspects of intervention	Open ended list	6 months
Pharmacists/family physician confidence in medication discontinuation	5 point Likert scale single question developed for study	Baseline, 6 months
Pharmacists/family physician experiences with the deprescribing process	Semi-structured interviews; field notes	6 months
Strengths and weaknesses of intervention	Open ended questions	6 months
Patient experience with deprescribing process (diary)	Patient diaries	6 months
Patient experience with deprescribing process (interview)	Semi-structured interview	6 months
Satisfaction with intervention	5 point Likert scale single question developed for study	6 months
Satisfaction with care around medications	5 point Likert scale single question developed for study	Baseline, 6 months
Cost effectiveness	Incremental cost per Quality Adjusted Life Year (payer perspective)	6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); David Braley and Nancy Gordon Chair in Family Medicine; RxISK

Publications and helpful links

General Publications

• Mangin D, Lamarche L, Agarwal G, Banh HL, Dore Brown N, Cassels A, Colwill K, Dolovich L, Farrell B, Garrison S, Gillett J, Griffith LE, Holbrook A, Jurcic-Vrataric J, McCormack J, O'Reilly D, Raina P, Richardson J, Risdon C, Savelli M, Sherifali D, Siu H, Tarride JE, Trimble J, Ali A, Freeman K, Langevin J, Parascandalo J, Templeton JA, Dragos S, Borhan S, Thabane L. Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial. Trials. 2021 Oct 26;22(1):746. doi: 10.1186/s13063-021-05685-9.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimated): October 24, 2016

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Polypharmacy; eHealth; Patient Preference; Randomized Control Trial; Multimorbidity; Drug Discontinuation
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction; Patient Preference
• Other Study ID Numbers: RN293982 - 367123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No